UNN-RADS Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer

Completed

• Conditions: Thyroid Cancer; Lymph Node
• Interventions: Diagnostic Test: US-guided fine needle aspiration (FNA)

• Registration Number: NCT06124469
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

In 2020, Sarda-Inman et al., developed the Ultrasound Neck Node Reporting and Data System (UNN-RADS) scale that allows decision-making about when it is appropriate to perform FNA of a cervical lymph node, evaluating seven ultrasonographic descriptors (shape, margins, echogenicity, echogenicity of the hilum, vascularity and the presence/absence of calcifications, and cystic degeneration), features that have been associated with metastatic lymph nodes, with scores ranging from 0 to 3 points, which allows categorize into 5 different risk groups. Thus, the objective of this study is to evaluate the ultrasound characteristics of metastatic LN in patients undergoing TC follow-up and to validate the UNN-RADS scale for the diagnosis of LN Metastasis in Patients with a history of TC.

Detailed Description

This study enrolled consecutive patients in follow-up for differentiated thyroid cancer (DTC) history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes. Patients were included if they 1) had previous history of DTC, 2) both sexes with age over 18 years old, and 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1. Patients were excluded if they underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer, had previous bilateral cervical lymph node dissection as initial treatment, or the FNA results were not concluded.

UNN-RADS 1 y 2 and UNN-RADS 3, 4 and 5 were grouped for analysis purpose. Diagnostic performance of UNN-RADS scale were assessed in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), positive likelihood ratios (+LR), negative likelihood ratios (-LR) and accuracy, as well as with a receiver operating characteristic (ROC) curve.

Study Timeline

• Study Start: 2022-03-15
• Primary Completion: 2023-10-23
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Last Update Submitted: 2023-11-06
• Study First Posted: 2023-11-09
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• 1. had previous history of DTC 2) both sexes with age over 18 years old 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1

Exclusion Criteria

• 1. underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer 2) had previous bilateral cervical lymph node dissection as initial treatment 3) FNA results were not concluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benign lymph nodes	US-guided fine needle aspiration (FNA)	Categories UNN-RADS 1 and 2 (test negative)
Metastatic lymph nodes	US-guided fine needle aspiration (FNA)	Categories UNN-RADS 3, 4, and 5 (test positive).

Primary Outcome Measures

Name	Time	Method
metastatic lymph node	All biopsy samples were sent to the pathology department of the unit, where final results were obtained in approximately 2-3 weeks.	Fine needle aspiration biopsy (FNA) results were the gold standard (metastatic or benign).

Trial Locations

Locations (1)

Unidad Medica de Alta Especialidad No. 1, Bajío; 🇲🇽 Leon, Guanajuato, Mexico